Public Announcement
Board Nominations Now Open: Digital Therapeutics Alliance Seeks Visionary Leaders to Represent the Diverse Membership and Global Ecosystem”
Digital Therapeutics Alliance (DTA), the leading global non-profit trade association for digital therapeutics (DTx), today announced plans to expand its Board of Directors in 2024 and 2025 to support the organization’s continued growth and evolution.
In 2024, the DTA Board will expand from its current 7 members to 10 members, plus the CEO. In 2025, the Board will further increase to 12 members, plus the CEO as a voting ex-officio member of the board. These additions will broaden the Board’s expertise and perspectives, enhancing governance and strategic leadership as the digital therapeutics industry matures.
“As digital therapeutics gain mainstream adoption, it is crucial that DTA’s leadership represents the diversity of our member organizations driving this healthcare revolution,” said Andy Molnar, DTA CEO. “Expanding our Board will allow greater representation to inform DTA’s mission of enabling patient access to high-quality, evidence-based digital therapeutics.”
DTA is seeking nominations from current members for the 2024 Board of Directors through October 13, 2023. Nominees should be senior executives with demonstrated strategy, board, and governance experience in digital health and commitment to DTA’s vision. Ideal candidates will contribute complementary knowledge across healthcare, technology and policy.
A Nomination Committee will review applications and propose candidates in November based on criteria such as leadership experience, subject matter expertise, and ability to fulfill Board member responsibilities. DTA’s industry membership will vote on final Board member selections in December.
New Board members will serve 3-year terms beginning in 2024. They will help shape DTA’s strategic direction, provide financial oversight, and drive the adoption of clinically-validated digital therapeutics worldwide.
For details on DTA’s Board nomination process, criteria, and application questions may be directed to Andy Molnar.
June 14, 2023 – Arlington, VA – Digital Therapeutics Alliance (DTA) is announcing the launch of the Policymaker & Payor DTx Evaluation Toolkit, a comprehensive set of resources to enable global healthcare and digital technology leaders to broaden the understanding, adoption, and integration of clinically evaluated digital therapeutics (DTx) into healthcare.
According to ISO, digital therapeutics “generate and deliver software-based medical interventions to patients to treat or alleviate a disease or disorder”. DTx products additionally provide clinicians and payors with robust opportunities to enhance clinical and health economic outcomes for patients and populations.
As part of its core mission, DTA continues to convene healthcare decision makers, end users, and industry leaders to develop a strong foundation for how patients and caregivers access and utilize digital therapeutics. This Toolkit originated through the work of the DTx Policy Coalition, which launched in June 2022, and provides clarity for healthcare decision makers responsible for evaluating and implementing DTx in real-world settings.
Components included in this Toolkit include:
In an increasingly fragmented landscape of differing product requirements and expectations within and across national jurisdictions, this Toolkit represents a first step toward enabling policymakers, payors, and manufacturers to harmonize baseline requirements and scale therapies across populations.
To that end, the Toolkit is equipped with an explanation of the benefits and challenges associated with developing and implementing DTx in clinical care, and provides education on the evaluation processes and metrics for assessing clinical benefits, risks, and patient preferences.
Through advocacy, education, and cross-industry collaboration, the Policymaker & Payor DTx Evaluation Toolkit will provide greater insight on the development and integration of DTx into healthcare, in an effort to ultimately improve patient outcomes and benefit global healthcare.
“Digital therapeutics will undoubtedly become a critical part of patient care. With the appropriate frameworks and pathways, this is the first treatment modality that can equitably scale across global healthcare settings to deliver personalized, high quality, impactful healthcare,” said Megan Coder, Chief Policy Officer of DTA. “The Policymaker & Payor DTx Evaluation Toolkit offers decision makers a full spectrum approach to understanding the complexities of DTx value assessment, legal and regulatory guidelines, and implementation, in addition to optimizing the impact of DTx therapies on patient care.”
These tools are free and open access, available to all: DTx Evaluation Toolkit – Digital Therapeutics Alliance.
About DTA
As the leading global authority on the evolution of digital health technology, Digital Therapeutics Alliance (DTA) is a 501(c)(6) non-profit trade association of industry leaders and stakeholders dedicated to the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors to improve clinical and health economic outcomes. As the leading international organization on digital therapeutic thought leadership and education, DTA provides the digital health ecosystem with the necessary tools to define, evaluate, and utilize DTx products.
Unlock the Future of Healthcare: Digital Therapeutics Alliance Inaugural Summit to Empower DTx Industry Leaders and Policymakers
Join the DTA Community June 7-9 for Three Days of Insight, Collaboration, and Innovation to Advance Digital Health Access and Equity for All.
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Arlington, VA —Digital Therapeutics Alliance (DTA) is proud to announce its Inaugural Summit, to be held June 7-9, 2023 at the Washington D.C. Marriott at Metro Center. The 3-day Summit programming will be facilitated by leaders from all facets of the digital therapeutics (DTx) ecosystem, including policymakers, manufacturers, payors, and other experts to guide innovation and equity in healthcare. The Summit programming will be led by DTA CEO, Andy Molnar, and will feature lively panel discussions and interactive workshop sessions that cover the advancement of DTx, healthcare policy impacts, reimbursement and regulatory pathways, clinical evidence requirements, and patient access optimization.
In addition to the Summit, DTA members and staff will also gather on Capitol Hill June 6-7, to meet with congressional members and staff to advocate for the Access to Prescription Digital Therapeutics Act (S. 723 and H.R. 1458). This bill seeks to create a new benefit category for digital therapeutics and ensure permanent coverage and reimbursement of DTx products by Medicare and Medicaid. Ensuring access to these clinically validated therapeutics for Medicare and Medicaid patients, and other high-risk, rural, and marginalized communities.
DTA’s vision is to bridge the gap between the DTx industry and the healthcare system by providing a platform for dialogue and collaboration between different stakeholders in the DTx space. With this Summit, DTA aspires to accelerate the adoption of digital therapeutics and ensure equitable access to healthcare for all.
The 2023 DTA Summit agenda will feature:
On Friday, June 9th, the DTA Summit’s final panel will bring together senior regulatory leaders from the U.S. Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS),The Office of the National Coordinator for Health Information Technology (ONC), The Substance Abuse and Mental Health Services Administration (SAMHSA),Agency for Healthcare Research and Quality (AHRQ), and National Institutes of Health (NIH) to provide insights on their own approaches to digital therapeutics. These agencies play a critical role in the development, classification, assessment, and distribution of digital therapeutics to patients.
DTA will host a Press Conference immediately following the Summit’s final panel. The announcements will be a defining moment in digital health worldwide, involving new standards, efforts, and publications that will:
DTA Board Member and Head of WELT USA, Danny Jooyoung Kim, PharmD shares, “The DTA Summit provides an excellent platform to connect with like-minded individuals and organizations and to stay up to date on the latest trends and advancements in this rapidly evolving field. We are excited to bring about a future where digital therapeutics become a vital component of patient care worldwide.”
DTA is committed to transforming global healthcare through the advancement of DTx, and the Inaugural Summit marks a significant milestone in that journey. DTA invites industry leaders and stakeholders to participate in this important event, helping shape the future of healthcare.
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Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn.
2023 Digital Therapeutics Alliance Inaugural Summit: DTx Industry Leaders Gather to Transform Global Healthcare
Held at the Washington D.C. Marriott at Metro Center June 7 – 9, 2023.
The 3-day Summit programming will be facilitated by leaders from all facets of the DTx industry, including policymakers, manufacturers, payors, and other experts to guide innovation and equity in healthcare.
The Digital Therapeutics Alliance (DTA) is hosting its Inaugural Summit on June 7-9, 2023 at the Washington Marriott at Metro Center. Leaders from all facets of the digital therapeutics (DTx) ecosystem, including policymakers, clinicians, and payors, will join DTA members to discuss the challenges and opportunities of DTx integration into the healthcare system and identify optimized policy, reimbursement, and regulatory pathways to accelerate adoption.
The 3-day Summit programming will be facilitated by Andy Molnar, Chief Executive Officer of DTA, and feature keynote presentations, panel discussions, and interactive sessions that cover the advancement of DTx, the impact of healthcare policy, reimbursement and regulatory pathways, clinical evidence requirements, and patient access optimization.
DTA’s Chief Executive Officer, Andy Molnar states: “We are here to transform healthcare and deliver a new category of medicine to patients to improve their lives. The 2023 DTA Inaugural Summit brings together the leaders in healthcare innovation that are making these monumental changes. We are building viable frameworks with partners from Capitol Hill, the investment ecosystem, clinicians, health plans, patients, and caregivers.”
DTx products use evidence-based, clinically evaluated technologies to optimize clinical and health economic outcomes, deliver high quality therapies to underserved populations, and transform how patients understand, manage, and engage in their healthcare.
Leading into the Summit, US-focused DTA members and staff will convene in Washington D.C. to meet with congressional members and other influential parties to advocate for the Access to Prescription Digital Therapeutics Act (S. 723 and H.R. 1458). This bill seeks to create a new benefit category for digital therapeutics and ensure permanent coverage and reimbursement of DTx products by Medicare and Medicaid.
Everett Crosland, DTA board member and Chief Commercial Officer for Cognito Therapeutics, commented, “Given the rapidly evolving reimbursement environment, DTA’s 2023 Inaugural Summit offers the DTx industry an unprecedented opportunity to engage and advocate on the issues that matter most to our companies, patients, providers, and payor partners. I’m excited to speak on emerging frameworks that are shaping our future.”
Learn more about: 2023 DTA Inaugural Summit event details and registration.
About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn.
Media Contact:
Autumn Brennan
Digital Therapeutics Alliance
abrennan@dtxalliance.org
Digital Therapeutics Alliance Applauds the Reintroduction of Bipartisan Legislation to Enable Public Coverage of Prescription Digital Therapeutics
Creating Medicare and Medicaid benefit categories for digital therapeutics (DTx) is a critical step toward expanded patient access and appropriate reimbursement.
March 9, 2023 — Arlington, VA — As the leading international organization on digital therapeutic (DTx) thought leadership and education, the Digital Therapeutics Alliance (DTA) welcomes the reintroduction of the Access to Prescription Digital Therapeutics Act (S. 723 and H.R. 1458). Upon passage, this bill will enable public coverage of prescription digital therapeutics, defined in this bill as a product that uses software to achieve its intended result, is cleared or approved by the Food and Drug Administration (FDA) for the prevention, management, or treatment of a medical condition, and is authorized by a qualified, licensed clinician.
If passed, the Access to Prescription Digital Therapeutics Act will establish a payment methodology for manufacturers of prescription digital therapeutics, product-specific Healthcare Common Procedure Coding System (HCPCS) codes, and a DTx manufacturer reporting process to the Centers for Medicare and Medicaid Services (CMS).
Championed by a bipartisan group of Congressional lawmakers under the leadership of Senators Jeanne Shaheen (D-NH) and Shelly Moore Capito (R-WV) and Representatives Kevin Hern (R-OK) and Mike Thompson (D-CA), the reintroduction of this legislation reflects the growing recognition of the clinical and health economic value that DTx products provide to patients, caregivers, and clinicians.
“Healthcare access is one of the hardest pain points to overcome, but innovation cannot be stifled simply because of how complex our healthcare system is to navigate. Patients covered by Medicare and Medicaid deserve equitable access to DTx therapies,” shares Andy Molnar, DTA Chief Executive Officer. “Additionally, commercial insurers look to federal leadership for coding and reimbursement, so it is of utmost importance that our government leadership does everything possible to pass the Access to Prescription Digital Therapeutics Act this year.”
This legislation comes at a critical moment for patients and marks an important step toward expanded patient access to DTx therapies for chronic and mental health conditions. Creating a DTx benefit category and access pathway for Medicare and Medicaid-covered populations will provide patients with remote access to therapies that can tremendously impact quality of life and healthcare outcomes. Expanded coverage for DTx products will also assist health systems and clinicians to better manage capacity, drive value, and serve communities.
Insights from the bill’s four co-sponsors include:
“Prescription Digital Therapeutics are tested and regulated like traditional prescription medication, so it’s commonsense that we remove barriers to care for those who respond positively to this kind of treatment,” said Shaheen. “Prescription digital therapeutics can help treat a range of diseases, including substance use disorders and mental health challenges, but many who need this treatment currently lack access. Our bipartisan, bicameral bill would remedy that issue by bringing this innovative care in line with traditional treatment so Medicare patients have control over their access to the therapies that work best for them.”
“The Access to Prescription Digital Therapeutics Act would allow more patients living with a broad variety of diseases and conditions – from Substance and Opioid Use Disorders and mental and behavioral health issues to diabetes and Parkinson’s disease – to more efficiently access the care and support they need and deserve,” Capito said. “Prescription Digital Therapeutics are an excellent example of how innovative technology can address some of the health challenges providers and patients continue to face. I’m proud to join my colleagues and reintroduce this important legislation.”
“Technology has tremendously improved our lives in so many ways, it’s time we apply that to our medical care. Prescription digital therapeutics will provide important benefits to patients – such as mental health resources for veterans – while unlocking untold potential in new technologies. I’m proud to introduce this legislation in the House to ensure Americans have access to cutting-edge care,” said Hern.
“Prescription digital therapeutics – software-based health care treatments – present significant benefits to patients and provide a new tool to help improve peoples’ lives,” said Thompson. “PDTs have been shown to benefit those with mental health issues like depression and substance abuse, providing an alternative to traditional medicine. I am proud to introduce this bipartisan bill alongside Senators Shaheen and Capito and Congressman Hern to ensure that seniors on Medicare have access to these innovative treatments.”
Digital therapeutics (DTx) have the potential to fill gaps in care for people and their families across the world. As a new category of medicine, DTx face numerous barriers in becoming fully integrated into traditional healthcare systems. To enable patients to receive access to DTx products that are convenient and effective, DTA and NCPDP co-hosted a workshop with stakeholders from across the U.S. healthcare system to map existing DTx integration and workflow pathways, while simultaneously identifying areas of improvement.
Workshop stakeholders included policymakers, clinicians, health systems, health plans, pharmacies, DTx product manufacturers, and patients.
Over the course of six months, between August 2022–January 2023, DTA and NCPDP brought together subject matter experts from relevant stakeholder groups to contribute to the development of this report which outlines the integration and workflow of DTx products in the healthcare system, using the patient journey – from diagnosis through DTx treatment – as the primary focal point.
DTA and NCPDP are committed to providing patients with access to healthcare and ensuring that clinicians have the ability to utilize and deliver innovative products like digital therapeutics to patients. This effort, led by Jessica Hauflaire, DTA Chief Operating Officer, will collaborate with stakeholders on addressing the next steps outlined in this report to optimize the healthcare system to meet the needs of clinicians and patients.
Preliminary findings (Feb 2023): DTx Integration & Workflow Workshop Report
In alignment with our mission to broaden the understanding, adoption, and integration of digital therapeutics (DTx) across the global healthcare system, the Digital Therapeutics Alliance (DTA) is hosting its first annual summit at the Washington Marriott Metro Center. As the leading international DTx industry organization, DTA is convening leaders in Washington, D.C. on June 7-9 from across the healthcare ecosystem to address the industry’s most pertinent challenges and opportunities.
Who should attend?
Clinicians, policymakers, payors, healthcare decision makers, patients, caregivers, product manufacturers, and other ecosystem leaders
Learn more about the event details and registration.
ARLINGTON, VA – December 14, 2022 – As the leading international organization on digital therapeutic (DTx) thought leadership and education, the Digital Therapeutics Alliance (DTA) welcomes the introduction of the ‘‘Medicaid and CHIP Access to Prescription Digital Therapeutics Act’’. This bipartisan legislation would provide guidance regarding coverage of prescription digital therapeutics under Medicaid and the State Children’s Health Insurance Program (CHIP).
This bipartisan legislation is championed by Senators Shelly Moore Capito (R-WV) and Jeanne Shaheen (D-NH) and reflects the growing recognition of the clinical and health economic value that digital therapeutics provide to patients, caregivers, and clinicians – especially given the increased barriers to care that Medicaid beneficiaries continue to face during and beyond the Covid-19 pandemic.
While Massachusetts and Oklahoma are already covering prescription digital therapeutics through their state Medicaid programs, this legislation provides much-needed clarity for other states intending to provide access to digital therapeutics and comes at a critical moment for patients, when many are unable to access other forms of necessary therapies. Using this guidance to leverage existing pathways to expand access to DTx products for Medicaid-covered populations will enable those with chronic and mental health conditions to access expanded care options that can make a tremendous difference in their quality of life and healthcare outcomes.
In addition to providing critical guidance to enable more standardized coverage decisions across the country, the Medicaid and CHIP Access to Prescription Digital Therapeutics Act (S.5238) would also allow the Secretary of Health and Human Services (HHS) to provide technical assistance to states considering coverage of FDA-approved or cleared prescription digital therapeutic products, and would define ‘prescription digital therapeutic’ within the context of Medicaid.
“Digital therapeutics hold particular value for Medicaid populations with convenient, accessible, and personalized treatment options to address many unmet medical needs,” says Andy Molnar, DTA Chief Executive Officer. “This legislation would establish more clarity and uniformity in how prescription digital therapeutics are covered by public programs from state to state and is a critical step toward ensuring that these evidence-based treatments get into the hands of those who need them most. We are grateful for the work of the bill sponsors and look forward to working with a broad coalition of patients, clinicians, and others to pass this into law.”
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About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn and Twitter.
Media Contact:
Hannah Fairman
Digital Therapeutics Alliance
hfairman@dtxalliance.org
Arlington, VA and San Francisco, CA – Tuesday, December 6, 2022 – The Digital Therapeutics Alliance (DTA), a global non-profit trade association with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare, in collaboration with DTA Resource Partner, Curebase, a company committed to democratizing access to clinical studies, today released a publication to provide a fit-for-purpose evidence standard for DTx product regulatory, reimbursement, and clinical acceptance.
The publication, “Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard”, outlines foundational principles specific to the DTx category of medicine and baseline expectations for healthcare decision makers (HCDMs) related to the types, quality, and timing of clinical trials necessary to evaluate and implement DTx therapies in real-world settings.
Given the profound growth of the DTx industry over the last decade, and as more HCDMs across the world embark on evaluating DTx products, it is important for clinicians, policymakers, and payors to have access to a harmonized, consistent set of study expectations to sufficiently demonstrate product safety, efficacy, and impact. Thus far, DTx products have been subject to the same clinical evidence standards that are used to assess the safety and effectiveness of other traditional medical devices and pharmaceuticals. However, given the unique nature of DTx products, it is increasingly clear that a fit-for-purpose evidence evaluation standard is required to account for the faster and iterative nature of DTx product life cycles, levels of potential risk, and their place in clinical therapy.
“For broader patient access to DTx therapies across the global marketplace, evaluation frameworks need to be clear, consistent, and specific to the unique characteristics of DTx products,” said Megan Coder, Chief Policy Officer of the Digital Therapeutics Alliance. “A fit-for-purpose DTx product evidence evaluation framework – reflective of how DTx products are designed and used in real-world settings – strengthens DTx evidentiary robustness and clarity, thereby preventing unnecessary delays in patient access to high-quality clinically-validated digital therapeutics.”
“Patients everywhere deserve access to high-quality care; having a fit-for-purpose evidence standard for DTx brings the industry one step closer to this,” says Whitney Stewart, Director of Clinical Project Management at Curebase. “By aligning the industry and providing the foundation for DTx studies, this paper paves the way for more thorough DTx studies, for a clearer path forward for DTx companies, and should result in overall better patient care.”
This publication provides evidence-based expectations for how DTx products should be validated by payors globally, building on principles from pharmaceutical and general medical device standards, while acknowledging digital therapeutics’ unique mechanisms of action, iterative development lifecycles, and clinical outcomes. To enable movement toward a fit-for-purpose DTx evidentiary standard, DTA will continue to engage with the broader healthcare ecosystem to develop harmonized and DTx-specific clinical evidence frameworks. For more information, and to download the paper, visit: https://dtxalliance.org/wp-content/uploads/2022/12/DTA-Clinical-Evidence-Paper_12.22.pdf.
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About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn and Twitter.
About Curebase
At Curebase, our mission is to bring quality medical innovations to patients faster and improve human well-being through more efficient clinical studies. We are proving that clinical research can be radically accelerated if we empower physicians everywhere to enroll patients in the communities where they live. By applying cutting-edge clinical software and remote study management techniques to the problem, we are reinventing clinical trials and research from the ground up. For more information, please visit www.curebase.com.
Tuesday, November 8, 2022 – Arlington, VA – Today, the Digital Therapeutics Alliance (DTA), is pleased to announce the results of the 2023 DTA Board of Directors election. With two seats up for election this cycle, DTA members selected Danny Kim, Head of WELT USA, as a new board member and re-elected Owen McCarthy, Co-Founder and President of MedRhythms, Inc. and current Chair to serve on the Board.
The 2023 DTA Board of Directors:
The Board of Directors supports DTA’s work to transform global healthcare by advancing digital therapeutics (DTx) and provides critical guidance related to the strategy and direction of the organization.
“We are looking forward to working with this Board to capitalize on the organizational initiatives already underway and tackle additional innovative efforts to advance digital therapeutics,” said Andy Molnar, DTA’s Chief Executive Officer. “These industry leaders will draw on their experience building successful companies to provide crucial support guiding DTA’s work to expand patient access to DTx products to improve clinical and health economic outcomes.”
DTA’s Board has set the strategic vision to transform global healthcare by advancing digital therapeutics and their oversight and guidance will be instrumental in ensuring successful execution:
Debra Reisenthel, Vice-Chair of the DTA Board of Directors, shares, “Strong leadership from industry trailblazers has been essential to support the rapid evolution of the DTx industry as well as the considerable growth of the Alliance, which now represents over 100 companies across 20 countries. I am excited to work with my fellow directors to pursue our strategic focus in 2023 on advancing adoption and integration of digital therapeutics on a global scale.”
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About DTA
The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding, adoption, and integration of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org or follow us on LinkedIn and Twitter.